Clinical Trial Using Pupillometry to Measure Nociception in Healthy Volunteers.

May 17, 2021 updated by: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Crossover Randomized Clinical Trial to Evaluate the Effectiveness and Safety of Pupillometry as an Objective Measurement of Nociception in Healthy Volunteers.

Pupillometry has been used in healthy volunteers to investigate the usefulness of the pupil light reflex as an indicator of pain intensity on pressure as a nociceptive stimulus. In this sense, it is necessary to check if the pupillometry is sensitive to different types or sources of pain. One of these devices is the Algiscan® portable pupillometer (IdMed, Marseille, France), which we propose to use in the present study. This pupillometer has previously been used in healthy volunteers, and in patients admitted to the intensive care unit, subjected to mechanical ventilation and sedation / analgesia.

This study in healthy volunteers aims to evaluate whether the PDR can be a reliable and discriminatory measure of the intensity of nociception, applying various types of nociceptive stimuli. If so, this study could lead to the use of pupillometry as an objective measure of nociception in settings where patients cannot communicate, such as intensive care areas or perioperative settings.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

Phase

Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Spain
- - Barcelona, Spain, 08041
    - Recruiting
    - Hospital De La Santa Creu I Sant Pau
    - Contact:
      
      Maria Rosa Ballester, PhD
      
      Email: mballesterv@santpau.cat
    - Contact:
      
      Phone Number: +34935537855

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

Subjects of both sexes (balanced)
Caucasian race
Ages between 25 and 65 years old (balanced, 50% from 25-45 and 50% from 45-65)
Body weight within the normal range (Quetelet index: 19-30)
Clinical history, physical examination and vital signs within normality
Free acceptance to participate, with written informed consent

Exclusion Criteria:

Previous history of alcoholism or drug dependence (year prior to the screening visit or daily alcohol consumption> 40 gr / day for men or> 24 gr / day for women)
Significant consumption of stimulating drinks (> 5 coffees, teas, chocolate or cola drinks / day).
Taking any medication in the 15 days prior to the study and / or medicinal plants that may have an effect on the pupil (beta-blockers, droperidol, metoclopramide, clonidine ...). Oral contraceptives and paracetamol will be allowed.
Pregnancy (β-hCG test).
Menstruation and / or dysmenorrhea on the day of the study
Family or personal history or clinical evidence of psychiatric, neurological or ophthalmological problems: anxiety, depression, Parkinson's, glaucoma, dry eyes, retinal diseases, eye surgery and pupil abnormalities, presenting migraine pathology and diabetes
Pupillary diameter ≥ 5mm
Smokers or ex-smokers <6 months.
Have participated in a clinical trial in the 3 months prior to the start of this study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Other
Allocation: Randomized
Interventional Model: Crossover Assignment
Masking: Double

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: threshold stimulation (tetanic)	Device: CE marked medical device Tetanic stimulation
Experimental: upper threshold stimulation (tetanic)	Device: CE marked medical device Tetanic stimulation
Experimental: threshold stimulation (pressure)	Device: Algometer Pressure stimulation
Experimental: upper threshold stimulation (pressure)	Device: Algometer Pressure stimulation
Placebo Comparator: non nociceptive procedure (fine touch)	Procedure: Comparator Non-nociceptive procedure (fine touch)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Pupillary Dilatation Reflex (PDR) Time Frame: Change in Pupillary Dilatation Reflex (PDR) from baseline to +10 minutes (with non-nociceptive procedure (fine touch))	Measure of Pupillary Dilatation Reflex (PDR) in % obtained by AlgiScan®	Change in Pupillary Dilatation Reflex (PDR) from baseline to +10 minutes (with non-nociceptive procedure (fine touch))
Change in Pupillary Dilatation Reflex (PDR) Time Frame: Change in Pupillary Dilatation Reflex (PDR) from baseline to 20 minutes after tetanic stimulation (by Algiscan®)	Measure of Pupillary Dilatation Reflex (PDR) in % obtained by AlgiScan® after tetanic stimulation (by Algiscan®)	Change in Pupillary Dilatation Reflex (PDR) from baseline to 20 minutes after tetanic stimulation (by Algiscan®)
Change in Pupillary Dilatation Reflex (PDR) Time Frame: Change in Pupillary Dilatation Reflex (PDR) from baseline to 30 minutes after tetanic stimulation (by Algiscan®)	Measure of Pupillary Dilatation Reflex (PDR) in % obtained by AlgiScan® after tetanic stimulation (by Algiscan®)	Change in Pupillary Dilatation Reflex (PDR) from baseline to 30 minutes after tetanic stimulation (by Algiscan®)
Change in Pupillary Dilatation Reflex (PDR) Time Frame: Change in Pupillary Dilatation Reflex (PDR) from baseline to 40 minutes after tetanic stimulation (by Algiscan®)	Measure of Pupillary Dilatation Reflex (PDR) in % obtained by AlgiScan® after tetanic stimulation (by Algiscan®)	Change in Pupillary Dilatation Reflex (PDR) from baseline to 40 minutes after tetanic stimulation (by Algiscan®)
Change in Pupillary Dilatation Reflex (PDR) Time Frame: Change in Pupillary Dilatation Reflex (PDR) from baseline to 50 minutes after tetanic stimulation (by Algiscan®)	Measure of Pupillary Dilatation Reflex (PDR) in % obtained by AlgiScan® after tetanic stimulation (by Algiscan®)	Change in Pupillary Dilatation Reflex (PDR) from baseline to 50 minutes after tetanic stimulation (by Algiscan®)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Pupillary Dilatation Reflex (PDR) Time Frame: Change in Pupillary Dilatation Reflex (PDR) from baseline to + 60 minutes after pressure estimulation	Measure of Pupillary Dilatation Reflex (PDR) in % obtained by AlgiScan® after pressure estimulation (by algometer Somedic®)	Change in Pupillary Dilatation Reflex (PDR) from baseline to + 60 minutes after pressure estimulation
Change in Pupillary Dilatation Reflex (PDR) Time Frame: Change in Pupillary Dilatation Reflex (PDR) from baseline to +70 minutes after pressure estimulation	Measure of Pupillary Dilatation Reflex (PDR) in % obtained by AlgiScan® after pressure estimulation (by algometer Somedic®)	Change in Pupillary Dilatation Reflex (PDR) from baseline to +70 minutes after pressure estimulation
Change in Pupillary Dilatation Reflex (PDR) Time Frame: Change in Pupillary Dilatation Reflex (PDR) from baseline to +80 minutes after pressure estimulation	Measure of Pupillary Dilatation Reflex (PDR) in % obtained by AlgiScan® after pressure estimulation (by algometer Somedic®)	Change in Pupillary Dilatation Reflex (PDR) from baseline to +80 minutes after pressure estimulation
Change in Pupillary Dilatation Reflex (PDR) Time Frame: Change in Pupillary Dilatation Reflex (PDR) from baseline to +90 minutes after pressure estimulation	Measure of Pupillary Dilatation Reflex (PDR) in % obtained by AlgiScan® after pressure estimulation (by algometer Somedic®)	Change in Pupillary Dilatation Reflex (PDR) from baseline to +90 minutes after pressure estimulation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 30, 2021

Primary Completion (Anticipated)

May 1, 2021

Study Completion (Anticipated)

May 1, 2021

Study Registration Dates

First Submitted

April 13, 2021

First Submitted That Met QC Criteria

April 26, 2021

First Posted (Actual)

April 28, 2021

Study Record Updates

Last Update Posted (Actual)

May 19, 2021

Last Update Submitted That Met QC Criteria

May 17, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

IIBSP-PUP-2019-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Clinical Trial Using Pupillometry to Measure Nociception in Healthy Volunteers.

Crossover Randomized Clinical Trial to Evaluate the Effectiveness and Safety of Pupillometry as an Objective Measurement of Nociception in Healthy Volunteers.

Study Overview

Status

Conditions

Intervention / Treatment

Study Type

Enrollment (Anticipated)

Phase

Contacts and Locations

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Genders Eligible for Study

Description

Study Plan

How is the study designed?

Design Details

Number of Arms

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Secondary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Collaborators and Investigators

Sponsor

Study record dates

Study Major Dates

Study Start (Actual)

Primary Completion (Anticipated)

Study Completion (Anticipated)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Actual)

Study Record Updates

Last Update Posted (Actual)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

Clinical Trials on Healthy

Clinical Trials on CE marked medical device

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